Posts Tagged: "enablement"

The most dominant, divisive issue in patent law over the last decade—Section101-eligibility and the Supreme Court’s Mayo-Alice framework—appears to have just become more divisive. Indeed, at least part of the reason for the controversy is that, with Mayo-Alice as the governing test, courts as a preliminary matter can decide Section101-eligibility based on considerations of an “inventive concept” and patentability—issues the Court once declared were “not relevant” to the separate eligibility provision of the Patent Act. Be that as it may, the Federal Circuit has recently issued certain decisions indicating that Section 101 now incorporates another vast area of invalidity; viz., the requirements for “enablement” under 35 U.S.C. §112(a). See, e.g., Customedia Technologies, LLC v. Dish Network Corp., 951 F.3d 1359, 1365-66 (Fed. Cir. March 6, 2020). In this article, we examine how this new requirement for Section 101 has emerged, the recent precedent on the issue, and the Patent Act’s requirements that undermine such Section 112(a) considerations for a Section 101-eligibilty test.

Regeneron has lost a significant battle in its fight with Kymab over patents for transgenic mice. In a 4-1 split decision today, the UK Supreme Court found the patents invalid for insufficiency, reversing the decision of the Court of Appeal. (Regeneron Pharmaceuticals Inc v Kymab Ltd. [2020] UKSC 27.) Regeneron had sued Cambridge, UK-based Kymab, alleging that the latter’s Kymouse transgenic mouse platform infringed two patents (EP 1,360,287 and EP 2,264,163) also known as the Murphy patents). The two patents at issue cover Regeneron’s VelocImmune platform, which is used to produce antibodies for treating diseases, including COVID-19. In February 2016, following a trial in the High Court, Mr Justice Henry Carr revoked the patents for insufficiency. However, in March 2018 the Court of Appeal reversed that finding and found the patents to be infringed in a judgment written by Lord Justice Kitchin.

The U.S. Court of Appeals for the Federal Circuit, in a precedential decision authored by Judge Taranto, today affirmed-in-part, vacated-in-part and remanded a decision of the U.S. District Court for the Central District of California in McRO, Inc. v. Bandai Namco Games America Inc. et. al. The case derives from the 2016 Federal Circuit decision determining that McRO’s challenged patent claims were directed to the display of lip synchronization and facial expressions of animated characters, which the court said were not directed to an abstract idea and were therefore patent eligible subject matter under 35 U.S.C. 101. In today’s ruling, the Court considered whether the district court’s decision on remand, which held that the Developer defendants and defendant-appellees “were entitled to summary judgment of noninfringement because the accused products do not practice the claimed methods and to summary judgment of invalidity because the specification fails to enable the full scope of the claims,” was correct.

One day before the now-famous Arthrex decision was issued, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided an appeal by Idenix Pharmaceuticals LLC and Universita Degli Studi Di Cagliari (collectively “Idenix”) against Gilead Sciences, Inc. (Gilead) that reiterates the extent to which the Court is split in its approach to so many issues. The precedential opinion was authored by Chief Judge Prost, with Judge Newman dissenting. In 2013, Idenix sued Gilead for infringement of U.S. Pat. No. 7,608,597 (the ‘597 patent), which claims a drug directed to the treatment of the hepatitis C virus (HCV). In response, Gilead argued that the ‘597 patent was invalid for failure to meet the written description and enablement requirements. At trial, the jury found for Idenix and upheld the validity of the patent. Gilead filed a renewed motion for Judgment as a Matter of Law (JMOL) on the written description and enablement requirements, and the court granted the motion only on enablement grounds, thus holding the patent invalid. The decision overturned the jury’s award to Idenix of $2.5 billion.

Since 2006, the U.S. Patent and Trademark Office (USPTO) has participated in the Patent Prosecution Highway Pilot Program (the PPH Program). Generally, the program is designed to accelerate examination of a given patent application as a result of examination of a corresponding application at another PPH-participating patent office having reached a positive ruling more quickly. If an application is eligible for and accepted into the PPH Program, the USPTO expedites processing of the application. Examiners also have the benefit of drawing from another examiner’s assessment of corresponding claims. Generally, existing data on the PPH Program has indicated that it is associated with increased allowance prospects and decreased examination times relative to non-PPH applications. However, the vast majority of this data is years old (e.g., from 2014). This article will briefly summarize the eligibility requirements for the program and present new data showing favorable allowance and pendency times. However, it will end with a warning: request entry to the PPH program in the United States at your own risk.

Last week, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, held an oversight hearing on the U.S. Patent and Trademark Office (USPTO) with Director Andre Iancu as the sole witness. A particular inquiry from Rep. Zoe Lofgren (D-CA) regarding the USPTO’s allegedly lax examination quality under 35 U.S.C. § 112 caught my attention. She remarked [at 1:33:30]:  “Theranos, the blood testing company whose founder is being investigated for fraud, was granted nearly 100 patents based on an invention that didn’t work; and it concerns me that a patent application for an invention that doesn’t work gets approved.”  She generally questioned examiners’ attention to Section 112 requirements. Rep. Lofgren’s statement was no doubt primed by information from the Electronic Frontier Foundation (EFF) in the Ars Technica blog post titled “Theranos: How a broken patent system sustained its decade-long deception.” In this article, the author, who was introduced as holding the “Mark Cuban Chair to Eliminate Stupid Patents” at EFF, declares with no evidence or proof, that the “USPTO generally does a terrible job of ensuring that applications meet the utility and enablement standards.” The article cited no study, identified no patent, nor any claim to any “invention that didn’t work.” This outrageous, baseless allegation is outright reckless and irresponsible.

From a conceptual standpoint, it would seem logical to assume that writing text to describe a particular invention ought to be easy for the inventor of that invention. Unfortunately, it isn’t that simple. While inventors are very good at inventing, they tend to be less good at many of the adjacent and necessary tasks along the road from invention to market success. Indeed, while an inventor undoubtedly knows the invention better than anyone else, it can be enormously difficult for inventors to describe their own inventions. The inventor of a new and useful invention is always in the best position to describe the invention. The problem lies with the reality that most inventors simply don’t understand what needs to be described in order to satisfy the U.S. patentability requirements. And, sadly, when inventors forgo professional assistance, they all too often wind up focusing their entire description of their inventions on how their new device or gadget will be used at the expense of describing the parts and pieces that make up the invention. This is an enormous mistake, and one from which there is often no recovery.

Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.

A jury in the United Stated Federal District Court for the District of Delaware recently delivered a verdict awarding nearly $24 million dollars in reasonable royalty damages to plaintiffs Bio-Rad Laboratories and the University of Chicago. Along with finding that defendant 10x Genomics had infringed upon patents covering genetic analysis technologies, the jury also found that 10x Genomics’ infringement was willful and found it “highly unprobable” (i.e., the words of the jury verdict form) that the asserted patent claims were valid.

Writing a patent application is not as easy as many think. Indeed, the concept of usefully describing the invention, which on its face seems easy enough to understand, is not as straight forward as it might seem, and why you cannot simply file an abbreviate description of an invention and think that suffices to protect anything really. This article looks at the most common parts of a patent application, and provides discussion about what each section needs to include.

The United States Patent and Trademark Office (USPTO) provides invalidity tools via inter partes review (IPR) and post-grant review (PGR), but which route is better? …  PGRs are estimated to cost more because of their broader discovery rules.  If cost is a major factor, IPRs are a less-expensive option due to restricted allowance of discovery, the most expensive aspect of patent litigation… If the invalidating arguments or art are not strong, an IPR may be a better option due to its lower threshold for institution.  The same prior art arguments that failed in a petition for a PGR may have succeeded in an IPR petition due to the lower standard.

“In sum, Defendants showed that epitaxially growing a monocrystalline layer directly on an amorphous layer would have required undue experimentation—indeed, that it is impossible,” the Federal Circuit found. The appellate court also found that Boston University created its own enablement problem by seeking a construction for “a non-single crystalline buffer layer” which included a purely amorphous layer. Along with reversing the district court’s denial of JMOL, the Federal Circuit dismissed-as-moot Boston University’s cross-appeal of the district court’s denial of attorney’s fees and enhanced damages.

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.

The enablement requirement is specifically aimed at ensuring the claimed invention is described with sufficient detail so the relevant person of skill in the art or technology area will understand both how to make and use what has been actually claimed in the patent… While there is no particularly concrete and useful definition for what specifically constitutes undue experimentation, the requirement generally mandates that the description explain the invention so that it could be made and used without individuals having to go through a trial and error process in order to figure it out for themselves. In other words, the invention must actually teach so the invention can be achieved.

You absolutely want to file a patent application with a description that is a mile wide — that part is good — but you also need to also drill down far more than one inch deep in order to teach the various nuances of at least the key aspects of the invention. And there are always nuances that can go a mile deep for any and every invention, no matter how simple it may seem to you as the inventor… How do you know how far you need to go? You really should strive to remove doubt and questions from the reader’s mind. While a certain amount of experimentation is allowable, and patents do not need to contain blueprint level detail, ask yourself whether a knowledgeable reader would know from what you’ve written enough to understand your invention without asking additional questions. If answers to additional questions would be necessary to fully comprehend the invention then answer those questions.